We need an alternative to loop diuretics
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VIDEO: Ultrafiltration’s role for acute heart failure remains uncertain

NATIONAL HARBOR, MD. – The trial designed to definitively test the safety and efficacy of ultrafiltration as an alternative to intravenous diuretics for patients hospitalized with acute decompensated heart failure got cut to about a quarter of its planned enrollment by the company that recently acquired the ultrafiltration technology. This outcomes means that ultrafiltration’s role in acute heart failure remains uncertain and will stay that way for the foreseeable future.

As a consequence, ultrafiltration (also known as aquapheresis), approved for use in the United States by the Food and Drug Administration in 2002, will be used by believers in the treatment on some of the estimated 200,000 or more U.S. heart failure patients who become hospitalized each year with acute, severe congestion that is unresponsive to diuretic treatment. Other clinicians who remain skeptical of ultrafiltration’s safety and efficacy will not use it, and currently no prospect remains to resolve this uncertainty. Also limiting ultrafiltration’s use is its designation as investigational by U.S. health insurers.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

“Early termination off the AVOID-HF [Aquapheresis Vs. Intravenous Diuretics and Hospitalization for Heart Failure] trial was a tragedy because it is unlikely we will ever see a trial of its size again,” commented Dr. G. Michael Felker during a discussion of treatment for acute heart failure at the at the annual meeting of the Heart Failure Society of America. “We still have no definitive answer” about ultrafiltration,” said Dr. Felker, professor of medicine and a cardiologist specializing in acute heart failure at Duke University in Durham, N.C.

Opinions about ultrafiltration and its role in treating patients with acute decompensated heart failure remain sharply split, although at this point, even proponents of the treatment concede that its use is limited to severely congested decompensated heart failure patients who prove unresponsive to intravenous diuretic therapy.

Dr. G. Michael Felker
Mitchel L. Zoler/Frontline Medical News
Dr. G. Michael Felker

Ultrafiltration is for patients with “recurrent decompensation (not the first episode) and a large amount of fluid overload (more than 10 pounds) who also have elevated central venous pressure and elevated abdominal pressure that reduces blood flow to the kidneys,” Dr. Maria Rosa Costanzo said in a video interview. Used in these patients at a low rate of 20-50 cc/hour to “gently remove fluid,” the treatment reduces central venous and intra-abdominal pressures, leading to increased urine output and restoration of diuretic sensitivity, said Dr. Costanzo, lead investigator for the AVOID-HF trial and medical director of the heart failure and pulmonary hypertension program at the Advocate Heart Institute in Naperville, Ill.

A dramatically opposing view of ultrafiltration came from Dr. Christopher M. O’Connor, a heart failure cardiologist and CEO of the Inova Heart and Vascular Institute in Falls Church, Va.

“Even in diuretic-resistant, patients I would not use ultrafiltration. It does not anymore fit into management” of acute decompensated heart failure patients, Dr. O’Connor said in an interview. The CARRESS-HF [Cardiorenal Rescue Study in Acute Decompensated Heart Failure] trial targeted patients with diuretic resistance, the very population we would need to treat, and we did not see an advantage to ultrafiltration,” said Dr. O’Connor, a coinvestigator on CARRESS-HF, an earlier trial that compared the two treatment methods (N Engl J Med. 2012 Dec 13;367[24]:2296-304).

“We need to understand who is the right patient” for ultrafiltration. “We need to continue to investigate [ultrafiltration] to know where it best fits,” commented Dr. Clyde W. Yancy, professor and chief of cardiology at Northwestern University in Chicago.


Dr. Clyde W. Yancy
Mitchel L. Zoler/Frontline Medical News
Dr. Clyde W. Yancy

AVOID-HF enrolled and randomized 224 patients with acute decompensated heart failure out of an anticipated enrollment of 810 patients. Analysis of the study’s primary endpoint, time to first heart failure event within the first 90 days following hospital discharge, occurred after an average of 34 days in 108 loop-diuretic treated patients and after an average 62 days in 105 ultrafiltration-treated patients, a difference that did not achieve statistical significance. A heart failure event within the first 90 days occurred in 25% of the ultrafiltration patients and in 35% of those on diuretic treatment, also a nonsignificant difference, Dr. Costanzo reported. Concurrent with her report at the meeting an article appeared online with the results (JACC Heart Fail. 2015;doi: 10.1016/j.jchf.2015.08.005).

Increases in serum creatinine were modest following ultrafiltration and similar to changes seen in the patients who received loop diuretic treatment. The biggest rise in average serum creatinine level occurred at 30 days after randomization, with an average 0.37 mg/dL rise among the ultrafiltration patients.

The abrupt shutdown in the AVOID-HF trial occurred following a change in ownership of the ultrafiltration technology used in the study. Ultrafiltration had been initially developed by CHF Solutions of Brooklyn Park, Minn. In 2010, Gambro, a Swedish company, acquired CHF Solutions and rights to the ultrafiltration system, and Gambro initiated the AVOID-HF trial. Baxter, in Deerfield, Ill., acquired Gambro in September 2013, and in April 2014, Baxter stopped the AVOID-HF trial because of slow projected enrollment, said Dr. Costanzo. But she strongly disagreed with this projection, and said that the trial showed no signs of futility or safety concerns when it came to a stop. Getting the data from Baxter to allow her and her associates to write their report and deliver their findings at the meeting took a lot of persuasion, Dr. Costanzo added.

 

 

Dr. Felker has been a consultant to and received research grants from 10 drug or device companies. He was a coinvestigator on the CARRESS-HF trial. Dr. Costanzo, lead investigator of AVOID-HF, said she had no relevant disclosures. Dr. O’Connor has been a consultant to ResMed, Roche Diagnostics, Cardiorentis, Bayer, and Actelion and has received research grants from Otsuka, ResMed, Roche Diagnostics. He was a coinvestigator on the CARESS-HF trial. Dr. Yancy had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

References

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Patients hospitalized with vascular congestion caused by an acute exacerbation of heart failure universally receive loop diuretics, but most patients continue to have persistent congestion and poor outcomes following treatment. In one recent trial, fewer than 20% of patients left the hospital with adequate decongestion regardless of whether they received high- or low-dose furosemide and whether they received it as a bolus or as a continuous infusion (N Engl J Med. 2011 Mar 3;364[9]:797-805). We need an alternative to decongestion by loop-diuretic treatment.

Ultrafiltration offers a number of potential advantages for treating acute congestion, especially for patients unresponsive to diuretic treatment. It provides a way to quickly and predictably remove isotonic fluid with no effect on electrolytes, no neurohormonal stimulation, and in several trials, no significant effect on renal function. It also can restore diuretic responsiveness,

Dr. Bradley A. Bart

Critics of ultrafiltration often cite the results of the CARRESS-HF [Cardiorenal Rescue Study in Acute Decompensated Heart Failure] trial, which I led (N Engl J Med 2012 Dec 13;367[24]:2296-304). I’m not convinced that the CARRESS-HF results apply to the large majority of patients with acute heart failure. All of the patients enrolled in this trial had acute kidney injury. Also, in CARRESS-HF, we used a control arm that received diuretic treatment in a stepped pharmacologic way, which is not the dosing strategy we usually see in community practice. In addition, CARRESS-HF did not use variable dosing in the ultrafiltration arm. A better comparison of diuretic treatment and ultrafiltration would use variable dosing in both arms.

That’s the design used in AVOID-HF. In this trial, clinicians adjusted both diuretic and ultrafiltration dosages based on the renal function and hemodynamics of each enrolled patient. Unfortunately, AVOID-HF ended too soon, after enrolling just a quarter of the patients calculated as necessary to produce a statistically significant difference in outcomes between the two treatment arms. This appeared to result in a nonsignificant trend in favor of ultrafiltration for the study’s primary endpoint. Despite being extremely underpowered, the results showed significant benefits for ultrafiltration for several secondary endpoints. The results also showed no deleterious effects on renal function with ultrafiltration.

If AVOID-HF had shown no signal of benefit from ultrafiltration then I think that would have meant to end of ultrafiltration, but that is not what happened. The strong trends in favor of ultrafiltration make the case to keep studying it for patients who have become unresponsive to diuretics. In these patients ultrafiltration is a good alternative. Several questions remain unanswered about the use of ultrafiltration, such as exactly when a patient has become too unresponsive to diuretic treatment to warrant using ultrafiltration, and how to optimally dose ultrafiltration. Despite this lingering uncertainty ultrafiltration remains a viable option that deserves more study.

Dr. Bradley A. Bart is professor of medicine at the University of Minnesota and chief of cardiology at Hennepin County Medical Center, both in Minneapolis. He had no financial disclosures. Dr. Bart was lead investigator for the CARRESS-HF trial and a coinvestigator on the AVOID-HF trial. He made these comments in a talk at the meeting and during an interview.

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Patients hospitalized with vascular congestion caused by an acute exacerbation of heart failure universally receive loop diuretics, but most patients continue to have persistent congestion and poor outcomes following treatment. In one recent trial, fewer than 20% of patients left the hospital with adequate decongestion regardless of whether they received high- or low-dose furosemide and whether they received it as a bolus or as a continuous infusion (N Engl J Med. 2011 Mar 3;364[9]:797-805). We need an alternative to decongestion by loop-diuretic treatment.

Ultrafiltration offers a number of potential advantages for treating acute congestion, especially for patients unresponsive to diuretic treatment. It provides a way to quickly and predictably remove isotonic fluid with no effect on electrolytes, no neurohormonal stimulation, and in several trials, no significant effect on renal function. It also can restore diuretic responsiveness,

Dr. Bradley A. Bart

Critics of ultrafiltration often cite the results of the CARRESS-HF [Cardiorenal Rescue Study in Acute Decompensated Heart Failure] trial, which I led (N Engl J Med 2012 Dec 13;367[24]:2296-304). I’m not convinced that the CARRESS-HF results apply to the large majority of patients with acute heart failure. All of the patients enrolled in this trial had acute kidney injury. Also, in CARRESS-HF, we used a control arm that received diuretic treatment in a stepped pharmacologic way, which is not the dosing strategy we usually see in community practice. In addition, CARRESS-HF did not use variable dosing in the ultrafiltration arm. A better comparison of diuretic treatment and ultrafiltration would use variable dosing in both arms.

That’s the design used in AVOID-HF. In this trial, clinicians adjusted both diuretic and ultrafiltration dosages based on the renal function and hemodynamics of each enrolled patient. Unfortunately, AVOID-HF ended too soon, after enrolling just a quarter of the patients calculated as necessary to produce a statistically significant difference in outcomes between the two treatment arms. This appeared to result in a nonsignificant trend in favor of ultrafiltration for the study’s primary endpoint. Despite being extremely underpowered, the results showed significant benefits for ultrafiltration for several secondary endpoints. The results also showed no deleterious effects on renal function with ultrafiltration.

If AVOID-HF had shown no signal of benefit from ultrafiltration then I think that would have meant to end of ultrafiltration, but that is not what happened. The strong trends in favor of ultrafiltration make the case to keep studying it for patients who have become unresponsive to diuretics. In these patients ultrafiltration is a good alternative. Several questions remain unanswered about the use of ultrafiltration, such as exactly when a patient has become too unresponsive to diuretic treatment to warrant using ultrafiltration, and how to optimally dose ultrafiltration. Despite this lingering uncertainty ultrafiltration remains a viable option that deserves more study.

Dr. Bradley A. Bart is professor of medicine at the University of Minnesota and chief of cardiology at Hennepin County Medical Center, both in Minneapolis. He had no financial disclosures. Dr. Bart was lead investigator for the CARRESS-HF trial and a coinvestigator on the AVOID-HF trial. He made these comments in a talk at the meeting and during an interview.

Body

Patients hospitalized with vascular congestion caused by an acute exacerbation of heart failure universally receive loop diuretics, but most patients continue to have persistent congestion and poor outcomes following treatment. In one recent trial, fewer than 20% of patients left the hospital with adequate decongestion regardless of whether they received high- or low-dose furosemide and whether they received it as a bolus or as a continuous infusion (N Engl J Med. 2011 Mar 3;364[9]:797-805). We need an alternative to decongestion by loop-diuretic treatment.

Ultrafiltration offers a number of potential advantages for treating acute congestion, especially for patients unresponsive to diuretic treatment. It provides a way to quickly and predictably remove isotonic fluid with no effect on electrolytes, no neurohormonal stimulation, and in several trials, no significant effect on renal function. It also can restore diuretic responsiveness,

Dr. Bradley A. Bart

Critics of ultrafiltration often cite the results of the CARRESS-HF [Cardiorenal Rescue Study in Acute Decompensated Heart Failure] trial, which I led (N Engl J Med 2012 Dec 13;367[24]:2296-304). I’m not convinced that the CARRESS-HF results apply to the large majority of patients with acute heart failure. All of the patients enrolled in this trial had acute kidney injury. Also, in CARRESS-HF, we used a control arm that received diuretic treatment in a stepped pharmacologic way, which is not the dosing strategy we usually see in community practice. In addition, CARRESS-HF did not use variable dosing in the ultrafiltration arm. A better comparison of diuretic treatment and ultrafiltration would use variable dosing in both arms.

That’s the design used in AVOID-HF. In this trial, clinicians adjusted both diuretic and ultrafiltration dosages based on the renal function and hemodynamics of each enrolled patient. Unfortunately, AVOID-HF ended too soon, after enrolling just a quarter of the patients calculated as necessary to produce a statistically significant difference in outcomes between the two treatment arms. This appeared to result in a nonsignificant trend in favor of ultrafiltration for the study’s primary endpoint. Despite being extremely underpowered, the results showed significant benefits for ultrafiltration for several secondary endpoints. The results also showed no deleterious effects on renal function with ultrafiltration.

If AVOID-HF had shown no signal of benefit from ultrafiltration then I think that would have meant to end of ultrafiltration, but that is not what happened. The strong trends in favor of ultrafiltration make the case to keep studying it for patients who have become unresponsive to diuretics. In these patients ultrafiltration is a good alternative. Several questions remain unanswered about the use of ultrafiltration, such as exactly when a patient has become too unresponsive to diuretic treatment to warrant using ultrafiltration, and how to optimally dose ultrafiltration. Despite this lingering uncertainty ultrafiltration remains a viable option that deserves more study.

Dr. Bradley A. Bart is professor of medicine at the University of Minnesota and chief of cardiology at Hennepin County Medical Center, both in Minneapolis. He had no financial disclosures. Dr. Bart was lead investigator for the CARRESS-HF trial and a coinvestigator on the AVOID-HF trial. He made these comments in a talk at the meeting and during an interview.

Title
We need an alternative to loop diuretics
We need an alternative to loop diuretics

NATIONAL HARBOR, MD. – The trial designed to definitively test the safety and efficacy of ultrafiltration as an alternative to intravenous diuretics for patients hospitalized with acute decompensated heart failure got cut to about a quarter of its planned enrollment by the company that recently acquired the ultrafiltration technology. This outcomes means that ultrafiltration’s role in acute heart failure remains uncertain and will stay that way for the foreseeable future.

As a consequence, ultrafiltration (also known as aquapheresis), approved for use in the United States by the Food and Drug Administration in 2002, will be used by believers in the treatment on some of the estimated 200,000 or more U.S. heart failure patients who become hospitalized each year with acute, severe congestion that is unresponsive to diuretic treatment. Other clinicians who remain skeptical of ultrafiltration’s safety and efficacy will not use it, and currently no prospect remains to resolve this uncertainty. Also limiting ultrafiltration’s use is its designation as investigational by U.S. health insurers.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

“Early termination off the AVOID-HF [Aquapheresis Vs. Intravenous Diuretics and Hospitalization for Heart Failure] trial was a tragedy because it is unlikely we will ever see a trial of its size again,” commented Dr. G. Michael Felker during a discussion of treatment for acute heart failure at the at the annual meeting of the Heart Failure Society of America. “We still have no definitive answer” about ultrafiltration,” said Dr. Felker, professor of medicine and a cardiologist specializing in acute heart failure at Duke University in Durham, N.C.

Opinions about ultrafiltration and its role in treating patients with acute decompensated heart failure remain sharply split, although at this point, even proponents of the treatment concede that its use is limited to severely congested decompensated heart failure patients who prove unresponsive to intravenous diuretic therapy.

Dr. G. Michael Felker
Mitchel L. Zoler/Frontline Medical News
Dr. G. Michael Felker

Ultrafiltration is for patients with “recurrent decompensation (not the first episode) and a large amount of fluid overload (more than 10 pounds) who also have elevated central venous pressure and elevated abdominal pressure that reduces blood flow to the kidneys,” Dr. Maria Rosa Costanzo said in a video interview. Used in these patients at a low rate of 20-50 cc/hour to “gently remove fluid,” the treatment reduces central venous and intra-abdominal pressures, leading to increased urine output and restoration of diuretic sensitivity, said Dr. Costanzo, lead investigator for the AVOID-HF trial and medical director of the heart failure and pulmonary hypertension program at the Advocate Heart Institute in Naperville, Ill.

A dramatically opposing view of ultrafiltration came from Dr. Christopher M. O’Connor, a heart failure cardiologist and CEO of the Inova Heart and Vascular Institute in Falls Church, Va.

“Even in diuretic-resistant, patients I would not use ultrafiltration. It does not anymore fit into management” of acute decompensated heart failure patients, Dr. O’Connor said in an interview. The CARRESS-HF [Cardiorenal Rescue Study in Acute Decompensated Heart Failure] trial targeted patients with diuretic resistance, the very population we would need to treat, and we did not see an advantage to ultrafiltration,” said Dr. O’Connor, a coinvestigator on CARRESS-HF, an earlier trial that compared the two treatment methods (N Engl J Med. 2012 Dec 13;367[24]:2296-304).

“We need to understand who is the right patient” for ultrafiltration. “We need to continue to investigate [ultrafiltration] to know where it best fits,” commented Dr. Clyde W. Yancy, professor and chief of cardiology at Northwestern University in Chicago.


Dr. Clyde W. Yancy
Mitchel L. Zoler/Frontline Medical News
Dr. Clyde W. Yancy

AVOID-HF enrolled and randomized 224 patients with acute decompensated heart failure out of an anticipated enrollment of 810 patients. Analysis of the study’s primary endpoint, time to first heart failure event within the first 90 days following hospital discharge, occurred after an average of 34 days in 108 loop-diuretic treated patients and after an average 62 days in 105 ultrafiltration-treated patients, a difference that did not achieve statistical significance. A heart failure event within the first 90 days occurred in 25% of the ultrafiltration patients and in 35% of those on diuretic treatment, also a nonsignificant difference, Dr. Costanzo reported. Concurrent with her report at the meeting an article appeared online with the results (JACC Heart Fail. 2015;doi: 10.1016/j.jchf.2015.08.005).

Increases in serum creatinine were modest following ultrafiltration and similar to changes seen in the patients who received loop diuretic treatment. The biggest rise in average serum creatinine level occurred at 30 days after randomization, with an average 0.37 mg/dL rise among the ultrafiltration patients.

The abrupt shutdown in the AVOID-HF trial occurred following a change in ownership of the ultrafiltration technology used in the study. Ultrafiltration had been initially developed by CHF Solutions of Brooklyn Park, Minn. In 2010, Gambro, a Swedish company, acquired CHF Solutions and rights to the ultrafiltration system, and Gambro initiated the AVOID-HF trial. Baxter, in Deerfield, Ill., acquired Gambro in September 2013, and in April 2014, Baxter stopped the AVOID-HF trial because of slow projected enrollment, said Dr. Costanzo. But she strongly disagreed with this projection, and said that the trial showed no signs of futility or safety concerns when it came to a stop. Getting the data from Baxter to allow her and her associates to write their report and deliver their findings at the meeting took a lot of persuasion, Dr. Costanzo added.

 

 

Dr. Felker has been a consultant to and received research grants from 10 drug or device companies. He was a coinvestigator on the CARRESS-HF trial. Dr. Costanzo, lead investigator of AVOID-HF, said she had no relevant disclosures. Dr. O’Connor has been a consultant to ResMed, Roche Diagnostics, Cardiorentis, Bayer, and Actelion and has received research grants from Otsuka, ResMed, Roche Diagnostics. He was a coinvestigator on the CARESS-HF trial. Dr. Yancy had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

NATIONAL HARBOR, MD. – The trial designed to definitively test the safety and efficacy of ultrafiltration as an alternative to intravenous diuretics for patients hospitalized with acute decompensated heart failure got cut to about a quarter of its planned enrollment by the company that recently acquired the ultrafiltration technology. This outcomes means that ultrafiltration’s role in acute heart failure remains uncertain and will stay that way for the foreseeable future.

As a consequence, ultrafiltration (also known as aquapheresis), approved for use in the United States by the Food and Drug Administration in 2002, will be used by believers in the treatment on some of the estimated 200,000 or more U.S. heart failure patients who become hospitalized each year with acute, severe congestion that is unresponsive to diuretic treatment. Other clinicians who remain skeptical of ultrafiltration’s safety and efficacy will not use it, and currently no prospect remains to resolve this uncertainty. Also limiting ultrafiltration’s use is its designation as investigational by U.S. health insurers.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

“Early termination off the AVOID-HF [Aquapheresis Vs. Intravenous Diuretics and Hospitalization for Heart Failure] trial was a tragedy because it is unlikely we will ever see a trial of its size again,” commented Dr. G. Michael Felker during a discussion of treatment for acute heart failure at the at the annual meeting of the Heart Failure Society of America. “We still have no definitive answer” about ultrafiltration,” said Dr. Felker, professor of medicine and a cardiologist specializing in acute heart failure at Duke University in Durham, N.C.

Opinions about ultrafiltration and its role in treating patients with acute decompensated heart failure remain sharply split, although at this point, even proponents of the treatment concede that its use is limited to severely congested decompensated heart failure patients who prove unresponsive to intravenous diuretic therapy.

Dr. G. Michael Felker
Mitchel L. Zoler/Frontline Medical News
Dr. G. Michael Felker

Ultrafiltration is for patients with “recurrent decompensation (not the first episode) and a large amount of fluid overload (more than 10 pounds) who also have elevated central venous pressure and elevated abdominal pressure that reduces blood flow to the kidneys,” Dr. Maria Rosa Costanzo said in a video interview. Used in these patients at a low rate of 20-50 cc/hour to “gently remove fluid,” the treatment reduces central venous and intra-abdominal pressures, leading to increased urine output and restoration of diuretic sensitivity, said Dr. Costanzo, lead investigator for the AVOID-HF trial and medical director of the heart failure and pulmonary hypertension program at the Advocate Heart Institute in Naperville, Ill.

A dramatically opposing view of ultrafiltration came from Dr. Christopher M. O’Connor, a heart failure cardiologist and CEO of the Inova Heart and Vascular Institute in Falls Church, Va.

“Even in diuretic-resistant, patients I would not use ultrafiltration. It does not anymore fit into management” of acute decompensated heart failure patients, Dr. O’Connor said in an interview. The CARRESS-HF [Cardiorenal Rescue Study in Acute Decompensated Heart Failure] trial targeted patients with diuretic resistance, the very population we would need to treat, and we did not see an advantage to ultrafiltration,” said Dr. O’Connor, a coinvestigator on CARRESS-HF, an earlier trial that compared the two treatment methods (N Engl J Med. 2012 Dec 13;367[24]:2296-304).

“We need to understand who is the right patient” for ultrafiltration. “We need to continue to investigate [ultrafiltration] to know where it best fits,” commented Dr. Clyde W. Yancy, professor and chief of cardiology at Northwestern University in Chicago.


Dr. Clyde W. Yancy
Mitchel L. Zoler/Frontline Medical News
Dr. Clyde W. Yancy

AVOID-HF enrolled and randomized 224 patients with acute decompensated heart failure out of an anticipated enrollment of 810 patients. Analysis of the study’s primary endpoint, time to first heart failure event within the first 90 days following hospital discharge, occurred after an average of 34 days in 108 loop-diuretic treated patients and after an average 62 days in 105 ultrafiltration-treated patients, a difference that did not achieve statistical significance. A heart failure event within the first 90 days occurred in 25% of the ultrafiltration patients and in 35% of those on diuretic treatment, also a nonsignificant difference, Dr. Costanzo reported. Concurrent with her report at the meeting an article appeared online with the results (JACC Heart Fail. 2015;doi: 10.1016/j.jchf.2015.08.005).

Increases in serum creatinine were modest following ultrafiltration and similar to changes seen in the patients who received loop diuretic treatment. The biggest rise in average serum creatinine level occurred at 30 days after randomization, with an average 0.37 mg/dL rise among the ultrafiltration patients.

The abrupt shutdown in the AVOID-HF trial occurred following a change in ownership of the ultrafiltration technology used in the study. Ultrafiltration had been initially developed by CHF Solutions of Brooklyn Park, Minn. In 2010, Gambro, a Swedish company, acquired CHF Solutions and rights to the ultrafiltration system, and Gambro initiated the AVOID-HF trial. Baxter, in Deerfield, Ill., acquired Gambro in September 2013, and in April 2014, Baxter stopped the AVOID-HF trial because of slow projected enrollment, said Dr. Costanzo. But she strongly disagreed with this projection, and said that the trial showed no signs of futility or safety concerns when it came to a stop. Getting the data from Baxter to allow her and her associates to write their report and deliver their findings at the meeting took a lot of persuasion, Dr. Costanzo added.

 

 

Dr. Felker has been a consultant to and received research grants from 10 drug or device companies. He was a coinvestigator on the CARRESS-HF trial. Dr. Costanzo, lead investigator of AVOID-HF, said she had no relevant disclosures. Dr. O’Connor has been a consultant to ResMed, Roche Diagnostics, Cardiorentis, Bayer, and Actelion and has received research grants from Otsuka, ResMed, Roche Diagnostics. He was a coinvestigator on the CARESS-HF trial. Dr. Yancy had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

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VIDEO: Ultrafiltration’s role for acute heart failure remains uncertain
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Key clinical point: Early halt to the AVOID-HF trial prevented the study from definitively comparing ultrafiltration with intravenous diuretic treatment in patients with acute decompensated heart failure.

Major finding: Average time to first heart-failure event was 62 days with ultrafiltration and 34 days with diuretic treatment, a nonsignificant difference.

Data source: AVOID-HF, a randomized trial that enrolled 224 patients at 30 U.S. centers.

Disclosures: AVOID-HF was initially sponsored by Gambro, which was later acquired by Baxter. Dr. Costanzo had no relevant disclosures.